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Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a 13 week, randomised, double blind study versus placebo and celecoxib.

Abstract：

OBJECTIVES:To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis OA in a 13 week, multicentre, randomised, double blind study. METHODS:After a 37 day washout period for nonsteroidal antiinflammatory drugs, 1702 patients with knee OA were randomised to lumiracoxib 200 or 400 mg once daily od, celecoxib 200 mg od, or placebo 2221. A visual analogue scale VAS pain intensity > or =40 mm was required. Primary efficacy variables were OA pain intensity VAS mm in the target knee, patients global assessment of disease activity VAS mm, and WOMAC pain subscale and total scores at 13 weeks. OA pain intensity, patients and physicians global assessment of disease activity, and WOMAC total and all subscale scores were analysed by visit as secondary variables. RESULTS:Lumiracoxib showed significant improvements in all primary and secondary variables compared with placebo. Lumiracoxib 200 mg od and celecoxib 200 mg od achieved similar improvements in OA pain intensity and functional status. Lumiracoxib 400 mg od demonstrated better efficacy for OA pain intensity and patients global assessment of disease activity at weeks 2, 4, and 8 and similar efficacy at week 13 compared with celecoxib 200 mg od. The incidence of adverse events AEs, serious AEs, and discontinuations due to AEs was similar in each group. CONCLUSION:Lumiracoxib demonstrated significant improvement in OA pain intensity, patients global assessment of disease activity, and the WOMAC pain subscale and total scores compared with placebo. Lumiracoxib was well tolerated in this study, with overall tolerability similar to that of placebo and celecoxib.

journal_name

Ann Rheum Dis

journal_title

Annals of the rheumatic diseases

authors

Tannenbaum H,Berenbaum F,Reginster JY,Zacher J,Robinson J,Poor G,Bliddal H,Uebelhart D,Adami S,Navarro F,Lee A,Moore A,Gimona A

doi

10.1136/ard.2003.015974

subject

Has Abstract

pub_date

2004-11-01 00:00:00

pages

1419-26

issue

eissn

0003-4967

issn

1468-2060

pii

ard.2003.015974

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a 13 week, randomised, double blind study versus placebo and celecoxib.